Profound expertise in EN ISO 13485 and GMP compliance
Medical device manufacturers must comply with different regulations, for example for the QM system, which are described in EN ISO 13485. Valicare offers you a broad spectrum of services.
Our extensive experience in the medical device, pharmaceutical, and biotechnology industries has enabled us to develop a deep understanding of EN ISO 13485, GMP compliance, and pharmaceutical quality management.
The latter form the basis for the development and implementation of a quality management system as well as the transition to EN ISO 13485:2016. Risk management is a comprehensive part of our work within quality management. We prepare design history files, device master records, and the technical documentation of your medical devices and support you throughout your supplier management process. We answer your questions about product qualification or process validation with risk-based concepts and hands-on support during their implementation.
We will be happy to join you on your way to a GMP-compliant manufacturing of your medical devices.
Find out more about our special GMP and ISO compliance services and Qualification for Medical Device Industry – or simply give us a call.
